NCT02625415

The Topical Application of Vitamin B6 in Palmar-Plantar Erythrodysesthesia

A Double Blind Placebo Control Randomised Trial to Test the Effectiveness of Vitamin B6 in Hand Foot Syndrome

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Cyprus University of Technology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study is designed to test the effectiveness of topical B6 cream in patients that developed Palmar-Plantar Erythrodysesthesia (Hand foot syndrome).

Detailed description

This will be a randomized double-blind, placebo-controlled study with 100 cancer patients that will receive chemotherapy treatment with capecitabine and/or pegylated liposomal doxorubicin. The selection of potential participants will be based on inclusion and exclusion criteria. Patients will be randomly allocated either to the treatment group or the placebo group. Treatment will be delivered daily (t.d.s) and assessments will take place at 0, 1, 2, 3 and 4 weeks. The intervention group will receive the application of topical vitamin B6 cream to the hands and/or feet of the patients and the control group will receive the placebo. At both baseline and follow-up, patients in both groups will be assessed for their degree of palmar-plantar erythrodysesthesia, the Quality of Life, the need for dose-limiting due to PPE and Pain intensity using standardized rating scales. Data will be analysed with inferential and descriptive statistics.

Conditions

• Palmar-Plantar Erythrodysesthesia

Interventions

Type	Name	Description
DEVICE	Vitamin B6 cream	Topical Vitamin B6 cream
DEVICE	Placebo Vitamin B6 cream	Placebo Vitamin B6 cream

Timeline

• Start date: 2016-07-01
• Primary completion: 2018-05-01
• Completion: 2018-06-15
• First posted: 2015-12-09
• Last updated: 2018-08-07

Locations

2 sites across 1 country: Cyprus